South Korea’s Green Cross Thursday announced it has received approval from the country’s health authorities to conduct phase II and phase III clinical studies of GC1102 (Hepavic-Gene), a new recombinant hepatitis B immunoglobulin (HBIg).

Green Cross shares closed Thursday up 0.23 percent at 221,500 won.

HBIg is an antibody against hepatitis B virus and this protein is extracted from pooled human plasma.

The company’s Hepavic is a champion product in this category. Hepavic-Gene was developed with recombinant DNA techniques applied to Hepavic, which is generally given to a patient after liver transplant to prevent the recurrence of hepatitis B virus infection.

Hepavic-Gene provides higher antibody purity and better antiviral potency compared to existing plasma-derived products, according to the company. The injection time can be reduced to one 60th of the previous time. In recognition of these benefits, Hepavic-Gene was designated as an orphan drug in the U.S. and Europe in 2013.

The two studies will be conducted almost simultaneously in patients undergoing liver transplant with underlying hepatitis B infection at nine hospitals across the country. The studies were designed to explore optimal dosage and evaluate efficacy and safety of the drug against existing therapies.

Green Cross is separately evaluating Hepavic-Gene for the indication of treating chronic hepatitis B.

By Kim Hye-soon and Minu Kim

[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]